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United States · US · US:47335-007_5330dfe5-b7e1-4813-bf9f-b3e932e61796
Entacapone
Orange BookUNIISPLATC N04BX02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN04BX02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114733500788100 TABLET, FILM COATED in 1 BOTTLE (47335-007-88)
Annotations
UNII (FDA Substance ID)
4975G9NM6T
ENTACAPONE
RxCUI 60307
Orange Book
N020796
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4975G9NM6T",
"rxcui": "60307",
"inchikey": "JRURYQJSLYLRLN-BJMVGYQFSA-N",
"display_name": "ENTACAPONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"56327e32-3b06-4144-91a0-bb1908842e33": {
"match": "brand_token",
"title": "ENTACAPONE TABLET [MACLEODS PHARMACEUTICALS LIMITED]",
"spl_version": "7",
"published_date": "2026-05-14"
}
},
"productid": "47335-007_5330dfe5-b7e1-4813-bf9f-b3e932e61796",
"productndc": "47335-007",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020796",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "200MG",
"product_no": "001",
"approval_date": "Oct 19, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENTACAPONE",
"proprietary_name": "Entacapone",
"active_ingred_unit": "mg/1",
"application_number": "NDA020796",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Entacapone",
"start_marketing_date": "20130401",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N04BX02.
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